rigin
Patients who have undergone HPC-C transplantation may develop post-transplant lymphoproliferative disorder (PTLD), manifested as a lymphoma-like disease favoring non-nodal sites. PTLD is usually fatal if not treated.
The incidence of PTLD appears to be higher in patients who have received antithymocyte globulin. The etiology is thought to be donor lymphoid cells transformed by Epstein-Barr virus (EBV). Serial monitoring of blood for EBV DNA may be warranted in high-risk groups.
Leukemia of donor origin also has been reported in HPC-C recipients. The natural history is presumed to be the same as that for de novo leukemia.
5.7 Transmission of Serious Infections
Transmission of infectious disease may occur because HEMACORD is derived from human blood. Disease may be caused by known or unknown infectious agents. Donors are screened for increased risk of infection with human immunodeficiency virus (HIV), human T-cell lymphotropic virus (HTLV), hepatitis B virus (HBV), hepatitis C virus (HCV),T. pallidum, T. cruzi, West Nile Virus (WNV), transmissible spongiform encephalopathy (TSE) agents, and vaccinia. Donors are also screened for clinical evidence of sepsis, and communicable disease risks associated with xenotransplantation. Maternal blood samples are tested for HIV types 1 and 2, HTLV types I and II, HBV, HCV, T. pallidum, WNV, and T. cruzi. These measures do not totally eliminate the risk of transmitting these or other transmissible infectious diseases and disease agents. Report the occurrence of a transmitted infection to the New York Blood Center at 1-866-767-NCBP (1-866-767-6227).
Testing is also performed for evidence of donor infection due to cytomegalovirus (CMV); however, this is not a donor selection criterion. The result may be found on the container label and/or in accompanying records.
5.8 Transmission of Rare Genetic Diseases
HEMACORD may transmit rare genetic diseases involving the hematopoietic system for which donor screening and/or testing has not been performed [See Adverse Reactions (6.1)]. Cord blood donors have been screened by family history to exclude inherited disorders of the blood and marrow. HEMACORD has been tested to exclude donors with sickle cell anemia, and anemias due to abnormalities in hemoglobins C, D, and E. Because of the age of the donor at the time HPC-C collection takes place, the ability to exclude rare genetic diseases is severely limited.
6 ADVERSE REACTIONS
Day-100 mortality from all causes was 25%.
The most common infusion-related adverse reactions (≥5%) are hypertension, vomiting, nausea, bradycardia, and fever.
6.1 Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Infusion Reactions
The data described in Table 1 reflect exposure to 442 infusions of HPC-C manufactured by various cord blood banks in patients treated using a total nucleated cell dose ≥2.5 x 107/kg on a single-arm trial or expanded access use (The COBLT Study). The population was 60% male and 40% female of median age 5 years (range 0.05-68 years), and included patients treated for hematologic malignancies, inherited metabolic disorders, primary immunodeficiencies, and bone marrow failure. Preparative regimens and graft-vs-host disease prophylaxis were not s |
